The Gaming of Pharmaceutical Patents

Abstract:     
Paragraph IV of the Hatch-Waxman Act provides a mechanism for the litigation of pharmaceutical patent infringement disputes. Many of these cases have been settled with "reverse payments" by the brand to the generic in return for delayed generic entry. The FTC has contested a number of these settlements with good but not complete success. This paper argues for per se illegality of settlements that include side payments or deals which are beneficial to the generic. Further, the paper shows a number of additional strategies beyond side payments, some highly questionable from an antitrust perspective, that brands have used to keep out generics.

Working Paper Series